The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
The standard of care will be supplied to all patients not receiving a drug intervention.
Andreas Barratt-Due
Oslo, Norway
RECRUITINGIn-hospital mortality
All cause in-hospital mortality
Time frame: 3 weeks
Occurrence and duration of mechanical ventilation
Time frame: 3 weeks
Occurrence and duration of intensive care unit (ICU) treatment
Time frame: 3 weeks
Duration of hospital admittance
Time frame: 1 month
28 Day mortality
Time frame: 3 weeks
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen
Time frame: 3 weeks
Occurrence of co-infections
Time frame: 3 weeks
Occurrence of organ dysfunction
Time frame: 3 months
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